To compare accumulation of liver fat (as measured using CAP) and liver fibrosis (as measured using fibroscan) between patients with quiescent and active inflammatory bowel disease
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure will be CAP en Emed (Fibroscan measures for steatosis
grade and fibrosis respectively)
Secondary outcome
Secondary study parameters: are to compare the relation between the following
parameters and liver steatosis/ fibrosis:
1. Mediterranean Diet Serving Scale, as a measure of healthy food intake.
2. Food related quality of life (FR-QoL), disease-specific quality of life
(sIBDQ) and general quality of life (SF-12)
3. Clinical activity of IBD (as assessed using symptom scores (Harvey-Bradshaw
index (HBI) for CD activity and the MAYO score for UC activity), CRP and fecal
calprotectin (the latter , as part of standard medical care)
4. Nutritional status and anthropometry (body weight, hand grip strength,
waist-hip ratio)
5. Medication use
6. In patients with active disease at baseline, accumulation of liver fat will
be compared between different types of medication used (steroids- mesalamine
compounds- immune-modulators and biologicals)
Background summary
Increased occurrence of non-alcoholic fatty liver disease (NAFLD) is observed
in patients with inflammatory bowel disease (IBD). Age, obesity, insulin
resistance and other metabolic conditions are common risk factors, but recent
data also point to IBD related factors such as disease activity, duration,
steroid use and prior surgical intervention, in the development of NAFLD.
Overall chronic inflammation, impaired intestinal barrier function and
microbial disturbances could play an important role in both IBD and NAFLD
pathogenesis. Additionally, commonly used immunosuppressive medication in the
treatment of IBD could potentially cause hepatic toxicity, but no conclusive
evidence exists linking them to the development of hepatic steatosis.
Furthermore, there are no data on the impact of fatty liver on IBD-therapy and
prognosis in patient with co-existent diseases. In this study, we aim to
compare the effect of active and quiescent disease on liver fat and liver
fibrosis.
Study objective
To compare accumulation of liver fat (as measured using CAP) and liver fibrosis
(as measured using fibroscan) between patients with quiescent and active
inflammatory bowel disease
Study design
This is an observational cohort study on accumulation of liver fat and
development of liver fibrosis in patients with active and queiescent
inflammatory bowel disease.
Study burden and risks
There is no additional risk involved. Treatment and follow-up will be according
to standard medical care. Participation will only involve filling in
questionnaires and undergoing a Fibroscan (non-invasive test,
www.fibroscan.com) at baseline and after regular follow-up clinical visits.
albinusdreef 2
Leiden 233ZA
NL
albinusdreef 2
Leiden 233ZA
NL
Listed location countries
Age
Inclusion criteria
Patient age >18 years
A confirmed diagnosis of either crohns disease, ulcerative colitis or IBD-unclassified.
Exclusion criteria
Patients unable or unwilling to provide informed consent
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61647.058.17 |